BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4011862 · Received August 15, 2014

    Report

    Report Number
    9612164-2014-01087
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    June 10, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEFORMATION PROBLEM.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT DEFORMED). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TARGET LESION EXHIBITED 100% STENOSIS, SEVERE CALCIFICATION AND SEVERE TORTUOSITY). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE NOT RETURNED FOR EVALUATION). EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (STENT DEFORMATION). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TARGET LESION EXHIBITED 100% STENOSIS, SEVERE CALCIFICATION AND SEVERE TORTUOSITY). (DEVICE NOT RETURNED FOR EVALUATION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO DEPLOY AN ENDEAVOR RESOLUTE 3.0X24 MM STENT. TARGET LESION WAS IN THE PROXIMAL RCA. LESION HAD SEVERE TORTUOSITY, SEVERE CALCIFICATION AND 100% STENOSIS. LESION WAS PRE-DILATED USING THREE BALLOONS, FIRST WITH A 1.5X12 MM BALLOON AND THEN WITH TWO 2.0X15 MM BALLOONS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. PHYSICIAN DECIDED TO WITHDRAW THE CATHETER AND NOTICED STENT WAS DEFORMED. PHYSICIAN FELT THAT THE DAMAGE WAS DUE TO THE DIFFICULTY OF THE LESION. DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. PHYSICIAN THEN TRIED TO CROSS THE SAME LESION WITH AN ENDEAVOR RESOLUTE 3.0X18 MM STENT TO TREAT A LESION IN THE DISTAL RCA. AGAIN RESISTANCE WAS MET AND STENT DEFORMATION OCCURRED. PHYSICIAN FELT THAT THE DAMAGE WAS DUE TO THE DIFFICULTY OF THE LESION. DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. PROCEDURE WAS COMPLETED WITH A THIRD ENDEAVOR RESOLUTE STENT (3.0X18MM). NO PATIENT COMPLICATIONS WERE REPORTED. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE RX) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY RX).

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE 1ST PROXIMAL SEGMENT OF THE STENT WAS DAMAGED, THE STRUTS WERE DEFORMED AND STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489170 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007034827

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR